1. Field of Invention
This present invention provides a miniature in-vivo robotic module to be used for conducting dexterous manipulations in a patient's abdominal cavity as part of Natural Orifice Transluminal Endoscopic Surgery (NOTES). The robotic module is a serial manipulator consisting of six actively controllable rotational degrees of freedom (DOF), thereby enabling an end effector equipped with a laparoscopic type instrument to assume a commanded position and orientation within the robot's workspace. This module may be anchored and guided to a designated location along the inner abdominal cavity wall via magnetic coupling forces imposed by magnets that are fixed to a different rigid and precise robotic manipulator located external to the patient. This present invention relates to the mechanical design, configuration, and functions of the in-vivo robotic module.
2. Description of Related Arts
Natural Orifice Transluminal Endoscopic Surgery has recently emerged as a step beyond laparoscopic methods for minimally invasive surgery (MIS), and often consists of surgery performed by passing an endoscope with tools through a natural orifice and into the abdominal or peritoneal cavities. A limited number of successful procedures have been documented involving transgastric and transvaginal appendectomies, transgastric and transvaginal cholecystectomies, and a transgastric peritoneoscopy. The majority of clinical trials have been performed on animal models, although a limited amount of human work has also been carried out. Transgastric approaches require instruments to be sent through the mouth, down the esophagus, and into the stomach. Once inside the stomach, a small incision is made for peritoneal access. However, secure closure of the access site is critically important such that anastomotic leaks do not occur. On the other hand, transvaginal approaches are popular as secure closure of the colpotomy wound can be accomplished using conventional methods.
Benefits of NOTES include a reduction in complications from wound infections, faster recovery times, generally less pain, better cosmesis, and a reduction in the need for post-operative care. However, potential barriers to clinical practice identified by the American Society of Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) include access to the peritoneal cavity, secure internal wound closure (especially gastric and intestinal), prevention of infection, proper suturing, maintaining the desired spatial orientation and visualization, management of intraperitoneal complications, physiologic untoward events, compression syndromes, the need for multidisciplinary training, and so on. Such challenges are compounded by the fact that there is no unifying architecture and multitasking platform for bringing together the existing relevant technologies. Due to the difficulty in developing techniques and technologies for overcoming these barriers, the NOTES surgical practice is still widely considered to be very much in its infancy.
There currently exist a limited number of endoscopic and robotic related NOTES navigation systems and platforms in either the prototype or preclinical stages. There are generally three categories of navigation platforms that have been developed. First, there are endoscope-based platforms, which include redesigned endoscopes such as NeoGuide (NeoGuide Medical Systems, USA), Transport™ and Cobra (USGI Medical, USA), and R-Scope (Olympus Medical Systems, Japan). Then, there are robotic-based platforms such as the master-slave surgical system (Nanyang Technological University, Singapore and National University of Singapore, Singapore) and ViaCath (EndoVia Medical, USA). Finally, there is the use of cooperative micro robots (Nebraska Surgical Solutions, USA). The 2-DOF planer manipulator micro-robot from Nebraska Surgical Solutions is the closest related device to the present invention; however, it is still significantly different in its functionalities and mechanical design.
Although each type of platform device has its relative advantages, there are several prevalent limitations, among which, include the inability to manipulate tissue with the required dexterity and forces, insufficient triangulation and maneuvering capability, and instruments with dimensions unacceptable for widespread clinical use. With the endoscope-based platforms, long and flexible instrumentation must be used. However, it is very difficult to achieve the desired forces, and small diameters prevent triangulation of the flexible instruments within the endoscope tool channels. For these such reasons, there is a lack of available flexible instruments, and several breakthroughs are still required for overcoming their limitations. Furthermore, the navigation platforms of all three categories generally have outer diameters (OD) that are prohibitively large and limit clinical potential. For example, redesigned endoscopes have ODs around 16 mm, whereas the micro-robots have ODs anywhere between 16 to 21 mm.
Based on the current state of NOTES, the Telemedicine and Advanced Technology Center (TATRC) is investing in new robotic systems that enable this procedure type and improve the surgical care of warfighters and their families. It is envisioned that to achieve extensive application of NOTES for improving the cost, quality, and access to surgical care, a novel and modular platform is necessary.